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Poster display session

4186 - JAVELIN Lung 100: updated design of a phase 3 trial of avelumab vs platinum doublet chemotherapy as first-line (1L) treatment for metastatic or recurrent PD-L1+ non-small-cell lung cancer (NSCLC)

Date

09 Sep 2017

Session

Poster display session

Topics

Cytotoxic Therapy;  Cancers in Adolescents and Young Adults (AYA);  Immunotherapy;  Non-Small Cell Lung Cancer

Presenters

Martin Reck

Citation

Annals of Oncology (2017) 28 (suppl_5): v460-v496. 10.1093/annonc/mdx380

Authors

M. Reck1, C. Yang2, P.E. Postmus3, F. Barlesi4, E.F. Font5, M. Thomas6, T.M. Kim7, M. Cobo Dols8, H. Skuladottir9, K. Park10, R. Sullivan11, A.L. Veatch12, N. Pavlakis13, L.M. Dreosti14, M. Özgüroğlu15, F. Morgillo16, M. Schlichting17, F. Teofilovici18, V. Chand19, V. Westeel20

Author affiliations

  • 1 Medical Oncology, LungenClinic, Airway Research Center North (ARCN), German Center for Lung Research (DZL), 22927 - Grosshansdorf/DE
  • 2 Medical Oncology, National Taiwan University Hospital, Taipei City/TW
  • 3 Medical Oncology, The Clatterbridge Cancer Centre, Liverpool/GB
  • 4 Medical Oncology, Aix Marseille University; Assistance Publique Hôpitaux de Marseille, Marseille/FR
  • 5 Medical Oncology, Hospital Universitari Vall d'Hebron, Barcelona/ES
  • 6 Medical Oncology, Thoraxklinik Heidelberg, Heidelberg/DE
  • 7 Medical Oncology, Seoul National University Hospital, Seoul/KR
  • 8 Medical Oncology, Hospital Universitario Málaga Regional y Virgen de la Victoria. IBIMA., Málaga/ES
  • 9 Medical Oncology, Herning Sygehus, Herning/DK
  • 10 Division Of Heamatology/oncology, Department Of Medicine, Samsung Medical Center, Seoul/KR
  • 11 Medical Oncology, Auckland Hospital, Auckland/NZ
  • 12 Medical Oncology, Northwest Medical Specialties, Puyallup/US
  • 13 Medical Oncology, Royal North Shore Hospital, Sydney/AU
  • 14 Medical Oncology, University of Pretoria, Pretoria/ZA
  • 15 Medical Oncology, Istanbul University, Istanbul/TR
  • 16 Medical Oncology, AOU Seconda Universita degli Studi di Napoli, Naples/IT
  • 17 Biostatistics, Merck KGaA, Darmstadt/DE
  • 18 Global Research & Early Development, EMD Serono, Inc., Billerica/US
  • 19 Medical Oncology, EMD Serono Inc., Billerica/US
  • 20 Chest Disease, Jean Minjoz University Hospital, Besançon Cedex/FR
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Resources

Abstract 4186

Background

Avelumab is a human anti–PD-L1 IgG1 antibody that has shown promising antitumor activity and manageable safety in several tumor types, including NSCLC, and is approved in the US for the treatment of metastatic Merkel cell carcinoma. Reports with anti–PD-(L)1 therapies suggest a role in 1L treatment of NSCLC using tumor PD-L1 expression selection criteria; however, optimal treatment for patients (pts) with different PD-L1 expression status is currently undefined. Preliminary exposure-response analysis from pts with NSCLC treated with avelumab 10 mg/kg Q2W in the JAVELIN Solid Tumor trial (NCT01772004) suggest enhanced antitumor activity with higher avelumab exposure. This phase 3 trial (NCT02576574) compares avelumab vs platinum doublet chemotherapy as 1L treatment for PD-L1+ NSCLC. Here, we describe the updated design, including an additional treatment arm to investigate the role of higher avelumab exposure in this setting.

Trial design

JAVELIN Lung 100 is an ongoing global, multicenter, randomized, open-label trial. The study protocol has been amended to demonstrate superiority of avelumab in prolonging PFS or OS as co-primary endpoints vs platinum doublet therapy, per RECIST v1.1 by blinded independent review. A hierarchical testing strategy will be applied to compare avelumab arms vs chemotherapy in terms of PFS and OS by PD-L1+ enriched populations (expression cutoff levels: high, moderate, and any, determined by the Dako 73-10 assay) at an overall significance level of 2.5% (one-sided). Eligibility criteria include: stage IV NSCLC, ECOG PS ≤ 1, no prior systemic treatment for advanced disease, and no EGFR mutation/ALK translocation. Approximately 1,095 pts will be randomized to 1 of 3 arms: arm A (avelumab 10 mg/kg 1-hour IV Q2W), arm B (investigator’s choice of specified platinum-based chemotherapy), or arm C (avelumab 10 mg/kg every week for 12 weeks, then 10 mg/kg Q2W), stratified by NSCLC histology and baseline tumor PD-L1 expression level. Secondary endpoints include objective response, duration of response, safety, pt-reported outcomes, PK, and biomarker assessments.

Clinical trial identification

NCT02576574 Protocol number: EMR 100070-005

Legal entity responsible for the study

Pfizer Inc., New York, NY, USA and Merck KGaA, Darmstadt, Germany.

Funding

Pfizer Inc., New York, NY, USA and Merck KGaA, Darmstadt, Germany.

Disclosure

M. Reck: Advisory Role: Roche, Lilly, BMS, MSD, Merck, AstraZeneca, Boehringer Ingelheim, Pfizer, Novartis, Celgene. Speaker’s Bureau: Roche, Lilly, BMS, MSD, Merck, AstraZeneca, Boehringer Ingelheim, Pfizer, Novartis, Celgene. C-H. Yang: Advisory Role: BI, Eli Lilly, Bayer, Roche/Genentech/Chugai, Astellas, MSD, Merck Serono, Pfizer, Novartis, Clovis Oncology, Celgene, Merrimack, Yuhan Pharmaceuticals, BMS, Ono pharmaceutical Daiichi Sankyo and Astrazeneca, Hansoh Pharmaceuticals. P.E. Postmus: Consulting: Celgene, BMS, Roche, Boehringer Ingelheim. Travel, Accomodations, expenses: Boehringer Ingelheim. Speaker\'s Bureau: Eli Lilly. F. Barlesi: Honoraria: Astra-Zeneca, Bristol-Myers Squibb, Boehringer–Ingelheim, Clovis Oncology, Eli Lilly Oncology, F. Hoffmann–La Roche Ltd, Novartis, Merck, MSD, Pierre Fabre and Pfizer. E.F. Font: Advisory Role: Eli Lilly, Pfizer, Roche, Boehringer Ingelheim, MSD. Speaker\'s Bureau: AstraZeneca, BMS, Novartis. M. Thomas: Grants/Research Support Recipient: Lilly, Pierre Fabre, BMS, AstraZeneca. Advisory Role: Lilly, Pierre Fabre, BMS, AstraZeneca, MSD, Novartis, Celgene, Roche, Pfizer. Honoraria: Lilly, MSD, Celgene, Roche. R. Sullivan: Travel, accommodations, expenses: BMS and Roche. N. Pavlakis: Grants/Research Support: Bayer. Advisory Role: Bayer, BI, AZ, MSD, BMS, Roche, Pfizer, Amgen, Merck Serono. L.M. Dreosti: Grants/Research Support: Novartis. Advisory Role: Novartis, Roche. Honoraria: MSD, Novartis, Janssens. Congress sponsorship: Roche, Merck, Janssens M. Özgüroğlu: Advisory Role: Sanofi. M. Schlichting: M.S. is an employee of Merck KGaA, Darmstadt, Germany. F. Teofilovici: F.T. is an employee of EMD Serono Inc. V. Chand: V.C. is an employee of EMD Serono Inc. V.C holds Bristol Myers Squibb stock. V. Westeel: Research funding: Roche, Genentech, BI, Merck Serono. Expert Testimony: Teva. Consulting: Pierre-Fabre Onc, MSD, Eli Lilly, AZ, BI, Novartis. Travel: Pierre-Fabre Onc, Roche, BMS, Eli Lilly, Merck Serono, Pfizer, BI. Speaker\'s Bureau: AZ, MSD, BMS, BI. All other authors have declared no conflicts of interest.

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